Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

This study has been completed.

First Received: April 30, 2002 Last Updated: July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034580

Purpose

This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: olanzapine Drug: risperidone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	326
Study Start Date:	August 2001
Estimated Study Completion Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subject, 18-70 years of age
Female subjects of childbearing potential must be using a medically accepted means of contraception
Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
Subjects must be considered reliable

Exclusion:

Female subjects who are either pregnant or nursing
Uncorrected hypothyroidism or hyperthyroidism
Narrow-angle glaucoma
Subjects who present a serious and immediate risk of endangering him or herself

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034580

Hide Study Locations

Locations

United States, California

Torrance, California, United States

San Marcos, California, United States

Los Angeles, California, United States

Orange, California, United States

Berkley, California, United States
United States, Colorado

Denver, Colorado, United States
United States, Connecticut

Middleton, Connecticut, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Winter Park, Florida, United States
United States, Idaho

Boise, Idaho, United States
United States, Illinois

Hoffman Estates, Illinois, United States
United States, Massachusetts

Natick, Massachusetts, United States
United States, Missouri

St Louis, Missouri, United States
United States, Nevada

Las Vegas, Nevada, United States
United States, New Jersey

Clementon, New Jersey, United States
United States, New York

Olean, New York, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
United States, Tennessee

Madison, Tennessee, United States
United States, Texas

Houston, Texas, United States
United States, Virginia

Roanoke, Virginia, United States

Richmond, Virginia, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	5528, F1D-US-HGJT
Study First Received:	April 30, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00034580 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Bipolar I Disorder

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Serotonin Antagonists
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Disease
Tranquilizing Agents

Bipolar Disorder
Gastrointestinal Agents
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009